PROBABLE UTILITY - Bereskin & Parr · 219 at para 146, 449 NR 111, Mainville JA [Eurocopter FCA], aff’g 2012 FC 113, 100 CPR (4th) 87, Martineau J [Eurocopter FC]. However, in Pfizer

199

PROBABLE UTILITY*

Robert H.C. MacFarlane**

ABSTRACT

This article discusses the legal requirements for making a sound prediction of utility and for disclosing an invention based on such a prediction. It argues that a sound prediction should be assessed from the subjective perspective of the inventors rather than the objective perspective of a skilled person, and that a sound prediction, like a demonstration, is simply evidence of utility to be assessed on a balance of probabilities. There is no reason at law to treat a demonstration differently from a sound prediction for the purposes of disclosure in a patent, and whether disclosure of facts and reasoning or a demonstration is required must be determined not by a judge-made rule of general application but by considering whether such disclosure is necessary, given the circumstances of the particular invention at issue, to satisfy the statutory requirement to disclose the invention and its operation or use as contemplated by the inventor.

RÉSUMÉ

L’article porte sur les exigences juridiques concernant la prédiction valable d’utilité et la divulgation d’une invention sur la base de cette prédiction. L’auteur soutient que la prédiction valable doit être évaluée du point de vue subjectif des inventeurs plutôt que du point de vue objectif de l’expert du domaine. Il affirme également qu’une prédiction valable, tout comme une démonstration, n’est qu’une preuve d’utilité qui devrait être évaluée selon le principe de la prépondérance des probabilités, et querien dans la loi ne justifie de traiter la démonstration différemment d’une prédiction valable à des fins de divulgation dans un brevet. L’auteur soutient de plus que, pour déterminer si la divulgation des faits et du raisonnement ou la démonstration est nécessaire, il faut se demander si cette divulgation est nécessaire, compte tenu du contexte entourant l’invention en cause, pour répondre aux exigences de la loi en matière de divulgation de l’invention ainsi que son fonctionnement ou son utilisation tel que conçue par l’inventeur, plutôt que de se baser sur une règle jurisprudentielle d’application générale.

Probable UtilityRobert H.C. MacFarlane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

1.0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2002.0 The Patent Act Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

2.1 Sections 2 and 27(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2042.2 Sections 27(1) and 40 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2062.3 Section 53 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

3.0 The Last Date for Establishing Utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2064.0 Sound Prediction: Objective and Subjective Perspectives . . . . . . . . . . . . . . . . . . . 2085.0 Probably Useful: Sound Prediction and Demonstration . . . . . . . . . . . . . . . . . . . . 2126.0 Proper Disclosure: The Onus of Proving Utility to the Commissioner . . . . . . . . . 2147.0 Proper Disclosure: Two Schools of Thought . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

7.1 Federal Court of Appeal: The Enhanced-Disclosure School . . . . . . . . . . . . 2167.2 Federal Court of Appeal: The No-Enhanced-

Disclosure School . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2177.3 The Federal Court . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2187.4 The Supreme Court of Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

8.0 Proper Disclosure: The Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2208.1 Section 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2218.2 Section 27 and Consolboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222

9.0 Proper Disclosure: Sound Prediction— The Skilled Person Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

10.0 Proper Disclosure: When Must Evidence of Utility Be Disclosed? . . . . . . . . . . . . 22711.0 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

* Submission to the editor, July 30, 2014.

** © 2015 Robert H.C. MacFarlane, Partner, Bereskin & Parr LLP, Toronto. The author wishes to thank Amrita V. Singh and Michael Burgess for their valuable assistance in research and editing.

200 CANADIAN INTELLECTUAL PROPERTY REVIEW 30 CIPR

CONTENTS

1.0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2002.0 The Patent Act Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

2.1 Sections 2 and 27(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2042.2 Sections 27(1) and 40 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2062.3 Section 53 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

3.0 The Last Date for Establishing Utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2064.0 Sound Prediction: Objective and Subjective Perspectives . . . . . . . . . . . . . . . . . . . 2085.0 Probably Useful: Sound Prediction and Demonstration . . . . . . . . . . . . . . . . . . . . 2126.0 Proper Disclosure: The Onus of Proving Utility to the Commissioner . . . . . . . . . 2147.0 Proper Disclosure: Two Schools of Thought . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

7.1 Federal Court of Appeal: The Enhanced-Disclosure School . . . . . . . . . . . . 2167.2 Federal Court of Appeal: The No-Enhanced-

Disclosure School . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2177.3 The Federal Court . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2187.4 The Supreme Court of Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

8.0 Proper Disclosure: The Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2208.1 Section 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2218.2 Section 27 and Consolboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222

9.0 Proper Disclosure: Sound Prediction— The Skilled Person Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

10.0 Proper Disclosure: When Must Evidence of Utility Be Disclosed? . . . . . . . . . . . . 22711.0 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

1.0 INTRODUCTION

The Supreme Court of Canada in Consolboard Inc v MacMillan Bloedel (Sask) Ltd1 (Consolboard) considered issues of utility, promised utility, and sufficiency of dis-closure on appeal from the decision of Jackett CJ in the Federal Court of Appeal. Dickson J, writing for the court, defined “useful” in the negative, holding that in patent law “not useful” means that an invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specifica-tion promises it will do. Disagreeing with the opinion of Jackett CJ, Dickson J held: “In my respectful opinion the Federal Court of Appeal erred also in holding that s. 36(1) requires distinct indication of the real utility of the invention in question”;2 the Patent Act3 does not require, in the disclosure or the claims, a distinct indication of how the invention is new or useful. Therefore, inventors need not extol the effect or advantage of the invention if they describe it so as to produce that effect or advan-tage. The only test for sufficiency is whether the specification adequately describes

1 [1981] 1 SCR 504, 56 CPR (2d) 145 [Consolboard].

2 Ibid at 525.

3 RSC 1985, c P-4, as amended [the Act].

30 RCPI REVUE CANADIENNE DE PROPRIÉTÉ INTELLECTUELLE 201

the invention for a person skilled in the art. It should answer the questions: “What is your invention? How does it work?” and it should enable the public—that is, skilled persons—to make the same successful use of the invention as the inventor could at the time of the application. Dickson J summed up as follows:

With respect, I agree with the submission of counsel for the appellant that the Federal Court of Appeal has confused the requirement of s. 2 of the Patent Act defining an in-vention as new and “useful,” with the requirement of s. 36(1) of the Patent Act that the specification disclose the “use” to which the inventor conceived the invention could be put. The first is a condition precedent to an invention, and the second is a disclosure requirement, independent of the first.4

The Supreme Court of Canada in Apotex v Wellcome5 (AZT ) considered the issue of a “sound prediction” of utility. Binnie J rejected the notion that speculation about utility was sufficient to support an invention. In the patent bargain, he reasoned, the public is entitled to “solid teaching” in return for a monopoly and this demands either a demonstration or a sound prediction of utility at the time the application is filed. He held that to make a sound prediction, an inventor must have a factual basis, an articulable and sound line of reasoning, and a proper disclosure. Binnie J indicated that he thought that a proper disclosure would include the predicted util-ity, as well as the factual basis and the line of reasoning for said prediction, but be-cause precise disclosure requirements were not in issue, he decided to “say no more about it.”6 He did, however, distinguish a number of cases in which the patents did not disclose utility on the ground that in each case the utility would have been ob-vious to the skilled person.7 And in spite of Dickson J’s criticism of Jackett CJ for having confused the definition of “invention” with the disclosure requirement and having erred in holding that section 36(1) (now section 27(3)) requires a distinct indication of the utility of the invention, Binnie J approvingly quoted Jackett CJ as follows:

As Jackett C.J. observed in Procter & Gamble Co. v. Bristol-Myers Canada Ltd. (1979), 42 C.P.R. (2d) 33 (F.C.A.), at p. 39:

By definition an “invention” includes a “new and useful process.” A “new” pro-cess is not an invention unless it is “useful” in some practical sense. Knowing a new process without knowing its utility is not in my view knowledge of an “invention.”8

4 Consolboard, supra note 1 at 527.

5 Apotex Inc v Wellcome Foundation Ltd, 2002 SCC 77, [2002] 4 SCR 153 [AZT ].

6 Ibid at para 70. This may indicate that the Supreme Court was not in agreement about the require-ments of “proper disclosure” for sound prediction, which would be consistent with LeBel’s J obiter comments to the contrary in Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60 at paras 39-40, [2012] 3 SCR 625 (sildenafil) [Teva v Pfizer], which are discussed below: see text surrounding note 17.

7 AZT, supra note 5 at para 54.

8 Ibid at para 52.


Since the AZT decision in 2002, the so-called doctrine of sound prediction has been the subject of many decisions in the Federal Court and the Federal Court of Appeal. The courts have extended its scope of application from the AZT-type of in-vention, where a “new use is the gravamen of the invention,”9 to encompass all types of inventions, including mechanical inventions.10 The sound prediction doc-trine applies to utility predictions about families of similarly active compounds based on structure - activity relationships,11 to specified ranges of the conditions or the states of materials or processes that are extrapolations or interpolations from more limited test results,12 and to mathematical calculations based on engineering principles.13 It is capable of being applied to any broadening of the scope of utility beyond empirical observations. The sound prediction doctrine not only has wide application but it also carries a severe penalty: if a patentee runs afoul of its rules, the patent is invalid.

The developing law of sound prediction has not held to a steady course. Over the past decade, the Federal Court and the Federal Court of Appeal have struggled to reconcile Consolboard and AZT, particularly with respect to the third aspect of the doctrine of sound prediction, the requirement for proper disclosure. One school of thought, following AZT, which appears to dominate at present, mandates an “en-hanced disclosure” that includes the factual basis and the line of reasoning that sup-port the prediction: in essence, evidence that the prediction of utility is sound. The other school of thought, following Consolboard, maintains that there is no enhanced disclosure required for sound prediction; there is no need to disclose or establish utility because the only disclosure requirement is mandated by section 27(3) of the Act, which is to disclose the invention and its operation or use as contemplated by the inventor.

The confluence of the developing law of the promise of the patent and the de-veloping law of sound prediction has led to further uncertainty, particularly in drug cases. Statements in a patent about potential, possible, or hoped-for results and ad-vantages may be construed as promises, particularly when they appear to be made to impress the Patent Office about the patentee’s tender of consideration in the patent bargain. Not having been demonstrated, such deemed promises may be treated as

9 Ibid at para 56.

10 Bell Helicopter Textron Canada Limitée v Eurocopter, société par actions simplifiée, 2013 FCA 219 at para 146, 449 NR 111, Mainville JA [Eurocopter FCA], aff’g 2012 FC 113, 100 CPR (4th) 87, Martineau J [Eurocopter FC]. However, in Pfizer Canada Inc v Ratiopharm Inc, 2010 FC 612 at para 90, 85 CPR (4th) 103 (sildenafil), Kelen J held that the doctrine does not apply to assessing a priority claim under section 28.1(1).

11 Alcon Canada Inc v Cobalt Pharmaceuticals, 2014 FC 462 (moxifloxacin); Sanofi-Aventis Canada Inc v Apotex Inc, 2009 FC 676, 77 CPR (4th) 99 (ramipril).

12 Teva Canada Ltd v Novartis AG, 2013 FC 141 at para 248, 109 CPR (4th) 1 (imatinib) [Teva v No-vartis]; Pfizer Canada Inc v Mylan Pharmaceuticals ULC, 2011 FC 547, 93 CPR (4th) 81 (donepezil).

13 Eurocopter FCA, supra note 10 at paras 147-148.


predictions of utility and subject to the rules of sound prediction. The patent will be invalid if the inventors do not have adequate facts and reasoning before the filing date to support the deemed predictions of utility. And even if they do have adequate facts and reasoning, the patent will be invalid under the enhanced-disclosure rules if the patent does not disclose these facts and reasoning. This is so even though the pat-ent may have been drafted before the enhanced-disclosure rules were pronounced.

The development of Canadian patent law over the past 12 years has been inter-esting, and patentees now fully understand the meaning of the reputed Chinese curse: “May you live in interesting times.” A comparison will illustrate. In the 22 years from 1980 until AZT in 2002, only 2 patents were held invalid for lack of util-ity and 1 for inadequate disclosure. In contrast, in the 12-year period since AZT, at least 18 patents were determined to be invalid for lack of utility or insufficient dis-closure. Although a boon for generic drug companies and defendants, this develop-ment in the law has been a source of considerable dissatisfaction for patentees. Exemplary of this dissatisfaction, on November 7, 2012, Eli Lilly served the gov-ernment of Canada with a Notice of Intent to Submit a Claim to Arbitration under NAFTA Chapter 11, relating to the patent for its drug “Strattera,” which had been held to be invalid. Then, on June 13, 2013, Eli Lilly withdrew the first notice and served a second Notice of Intent to Submit a Claim to Arbitration under NAFTA Chapter 11 for patents in respect of two drugs: “Strattera” and “Zyprexa.”

The pendulum that had swung against patentees has, however, begun to swing back. In Sanofi-Aventis v Apotex Inc,14 Pelletier J noted the caution in Consolboard that there is no occasion for being too astute or technical in the matter of objections to either title or specification15 and, speaking of the promise of the patent doctrine, said: “Courts should not strive to find ways to defeat otherwise valid patents.”16 In 2012, LeBel J of the Supreme Court of Canada, albeit in obiter dicta,17 spoke out against the need for enhanced disclosure in sound prediction cases. The Supreme Court also granted leave to appeal in Apotex Inc v Sanofi-Aventis,18 a case where in the courts below the “promise of the patent” and “sound prediction” were in issue. The appeal was discontinued by Apotex in November 2014.

This article discusses the legal requirements for making a sound prediction of utility and for disclosing an invention based on such a prediction. It argues that a sound prediction should be assessed from the subjective perspective of the inven-tors rather than the objective perspective of a skilled person, and that a sound pre-diction, like a demonstration, is simply evidence of utility to be assessed on a

14 2013 FCA 186 at para 54, 114 CPR (4th) 1 (clopidogrel) [Sanofi-Aventis v Apotex].

15 Consolboard, supra note 1 at 520-21.

16 Sanofi-Aventis v Apotex, supra note 14 at para 54.

17 Teva v Pfizer, supra note 6 at paras 39-40.

18 2011 FC 1486, 101 CPR (4th) 1, rev’d 2013 FCA 186, 114 CPR (4th) 1, leave to appeal to SCC granted, [2013] SCCA No 406 (clopidogrel).


balance of probabilities. There is no reason to treat a demonstration differently from a sound prediction for the purposes of disclosure in a patent, and whether disclo-sure of facts and reasoning or a demonstration is required must be determined, not by a judge-made rule of general application, but rather by considering whether such disclosure is necessary, given the circumstances of the particular invention at issue, to satisfy the statutory requirement to disclose the invention and its operation or use as contemplated by the inventor.

2.0 THE PATENT ACT PROVISIONS

When considering utility and disclosure, courts usually refer to the definition of “in-vention” in section 2 of the Act, and the disclosure requirements in section 27(3). The Patent Rules19 concerning the patent abstract are also of marginal interest.

In AZT, Binnie J also considered section 40 of the Act, regarding the commis-sioner’s duty to refuse a patent application. The counterpart of section 40 is section 27(1), which addresses the commissioner’s duty to grant a patent.

Section 53 of the Act may also play a role when considering when a court should grant a remedy for omissions from the disclosure.

2.1 Sections 2 and 27(3)

Section 2 defines “invention” as follows:

“invention” means any new and useful art, process, machine, manufacture or compos-ition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.

Section 27(3) defines the disclosure requirements of a patent specification as follows:

27(3) The specification of an invention must

(a) correctly and fully describe the invention and its operation or use as con-templated by the inventor;

(b) set out clearly the various steps in a process, or the method of constructing, making, compounding or using a machine, manufacture or composition of matter, in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which it pertains, or with which it is most closely connected, to make, construct, compound or use it;

(c) in the case of a machine, explain the principle of the machine and the best mode in which the inventor has contemplated the application of that principle; and

19 SOR/96-423 [the Rules].


(d) in the case of a process, explain the necessary sequence, if any, of the vari-ous steps, so as to distinguish the invention from other inventions.

Section 2 defines an invention with the word “useful,” which is seldom discussed in the cases; “utility” is the more common term. “Utility” means “usefulness”—that is, the quality of being useful or how something may be useful. The word “utility” is not found in any provision of the Act, but it is mentioned in two rules, which by reason of section 12(2) of the Act have the force of enactments.20 The rule of cur-rent interest is rule 79, which speaks of the “use or uses” of the invention rather than its “utility.”21

Section 27(3)(a) of the Act requires disclosure of “the invention and its operation or[22] use as contemplated by the inventor.” This is a general requirement for all types of inventions. Each of sections 17(3)(a) through (d) sets out individual require-ments for particular types of inventions. This article concentrates on the general re-quirement, which is adequate for the purposes of this discussion.

20 The word “utility” appears twice in the Rules: rule 139 in part IV, Applications Having a Filing Date in the Period Beginning on October 1, 1989 and Ending on September 30, 1996, under the heading “Form and Contents of Applications,” and in rule 175 in part V, Applications Having a Fil-ing Date Before October 1, 1989, under the heading “Form and Contents of Applications.” Both rules have the same wording:

139(1) An application shall contain an abstract that provides technical information and that cannot be taken into account for the purpose of interpreting the scope of the protection sought or obtained.

(2) The abstract shall consist of a brief technical statement of the description indicative of the utility of the invention and the manner in which the invention is distinguishable from other inventions.

Each rule requires an abstract to contain “a brief technical statement of the description indica-tive of the utility of the invention.” Each rule also provides that the abstract “cannot be taken into account for the purpose of interpreting the scope of the protection sought or obtained.” The effect of these rules is to require the inventor to disclose in the abstract what is contemplated to be the utility of the invention, without that disclosure having any effect on the inventor’s rights. However, both rules apply to older applications that are likely of little interest today except to understand the context of the Act and the Rules at the time of earlier decisions.

21 Rule 79 is applicable to most applications of interest today. It, too, provides that an abstract cannot be taken into account for the purpose of interpreting the scope of protection sought or obtained. The word “utility” is no longer used. The comparable section 79(4) reads:

79(4) The abstract shall be drafted in a way that allows the clear understanding of the technical problem, the gist of the solution of that problem through the invention, and the principal use or uses of the invention.

22 The word “or” is used in both ss 27(3)(a) and (b) and its meaning is unclear. It could mean either that any one of the listed requirements is sufficient compliance (which seems incorrect, especially in s 27(3)(b)), or that the ones most appropriate to the type of invention are intended.


2.2 Sections 27(1) and 40

Sections 27(1) and 40 respectively empower the commissioner of patents to grant or refuse patent applications:

27(1) The Commissioner shall grant a patent for an invention to the inventor or the inventor’s legal representative if an application for the patent in Canada is filed in ac-cordance with this Act and all other requirements for the issuance of a patent under this Act are met.

40. Whenever the Commissioner is satisfied that an applicant is not by law entitled to be granted a patent, he shall refuse the application and, by registered letter ad-dressed to the applicant or his registered agent, notify the applicant of the refusal and of the ground or reason therefor.

2.3 Section 53

Section 53 of the Act is also relevant to the effect of an omission in a specification and drawing that is “necessary for obtaining the end for which they purport to be made.” It reads:

53(1) A patent is void if any material allegation in the petition of the applicant in respect of the patent is untrue, or if the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made, and the omission or addition is wilfully made for the purpose of misleading.

(2) Where it appears to a court that the omission or addition referred to in subsec-tion (1) was an involuntary error and it is proved that the patentee is entitled to the re-mainder of his patent, the court shall render a judgment in accordance with the facts, and shall determine the costs, and the patent shall be held valid for that part of the in-vention described to which the patentee is so found to be entitled.

3.0 THE LAST DATE FOR ESTABLISHING UTILITY

The date for establishing that an invention is useful is not stated expressly in the Act, but it is implicit. Section 27(1) allows the commissioner to grant a patent for an invention if an application is filed in accordance with the Act. Section 27(2) re-quires the application to include a specification of the invention. Section 2 defines an invention to be novel and useful subject matter. Section 28(1) provides that the “filing date” is the date when the commissioner receives everything that is required. Therefore, at the time of filing, an inventor must have invented and described novel and useful subject matter. If that is not the case, the application is not filed in ac-cordance with the Act.

In AZT, Binnie J scotched the idea that utility could be supported with data ac-quired after the filing date of the patent application—the law of sound prediction should not be diluted to a lucky guess that turns out to be correct; the patent bargain demands “hard coinage.” Binnie J expressed the rule as follows: “[T]he inventor


[must be] in a position to establish utility as of the time the patent is applied for, on the basis of either demonstration or sound prediction.”23

In the remainder of this passage, Binnie J goes on to suggest that section 40 puts the onus on an applicant to establish utility to the satisfaction of the commissioner of patents on pain of refusal of the application. This proposition, which perhaps was driven by Binnie J’s view of what must be disclosed in a specification for an in-vention based on a prediction of utility, is discussed later in relation to disclosure requirements.

Note that Binnie J said that the time for a demonstration or a sound prediction of utility is “the time the patent is applied for.” He later clarified that he meant the pri-ority date. For example:

[56] Where the new use is the gravamen of the invention, the utility required for patentability (s. 2) must, as of the priority date, either be demonstrated or be a sound prediction based on the information and expertise then available.24

And:

[71] It bears repetition that the soundness (or otherwise) of the prediction is a question of fact. Evidence must be led about what was known or not known at the pri-ority date, as was done here.25

It does not appear that the submissions in AZT directed Binnie J to consider that an application may be amended in the time interval between the priority filing date and the Canadian filing date. In this interval, an inventor, and even others not named in the priority document, may conduct further development work on the in-vention. Consequently, the Canadian application may contain additional subject matter and other inventors, although the priority claim will be restricted to the sub-ject matter disclosed in the priority document.

The Federal Court of Appeal has since established that the Canadian filing date is the final deadline for establishing the support of facts and reasoning for a sound prediction.26 It is logical that this is also the time limit for demonstrating utility.

The law is clear that inventors cannot rely on demonstrations, facts, or reasoning that become available after the Canadian filing date to support a claim that the inven-tion has general utility or fulfills a promise in the patent of some specified utility.


24 Ibid at para 56 (emphasis in original).

25 Ibid at para 71.

26 Aventis Pharma Inc v Apotex Inc, 2006 FCA 64, 46 CPR (4th) 401, Richard CJ, aff’g 2005 FC 1283, 43 CPR (4th) 161, leave to appeal to SCC refused, file no 31414 (3 August 2006) (ACE inhibitors).


4.0 SOUND PREDICTION: OBJECTIVE AND SUBJECTIVE PERSPECTIVES

The Federal Court uses different approaches to assess whether inventors have made a sound prediction of utility, which may be described as subjective and objective perspectives. The consequences of choosing one or the other are significant to de-termining when and if an invention based on a prediction of utility has been made.

Snider J, in Merck & Co v Apotex Inc, said that a prediction of utility should be evaluated from the perspective of the inventors. She described this as a subjective perspective and characterized it as follows:

The question of sound prediction is one of fact (Wellcome AZT … [2002 SCC 77, [2002] 4 SCR 153] at para. 71). The inventors must be able to show that, at the rel-evant time, they were in possession of a factual basis upon which they could articulate the desired result. The perspective being examined at this stage is a subjective one. The knowledge, activities and endeavours of the inventors themselves must be considered.27

On the other hand, Hughes J, in Eli Lilly Canada Inc v Apotex Inc,28 used the ob-jective perspective of the person skilled in the art to assess sound prediction:

[157] Thus the prediction that a person skilled in the art in 1992, the priority date, could reasonably make was turned to one that such a person would soundly or inevit-ably make as of the Canadian filing date in 1993.

The facts of Eli Lilly Canada v Apotex provide a good backdrop for a discussion of these different perspectives. The inventors were Black and Cullinan, the latter playing no role in the reasons; Jones was a colleague of Black; and Jordan, Feld mann, Turner, and Love were authors of prior art. Hughes J summarized the facts as follows:

• Late1980s,osteoporosisisaproblemexperiencedparticularlyinpost-menopausalwomen, estrogen therapy runs the risk of cancer.

• JonesandBlackbothworkingforEliLillyhaveareportedhistoryofworkingwith keoxifene (raloxifene).

• Jordan1987,testsareconductedonratsusingtamoxifenandkeoxifene(raloxi-fene) recommending at least for tamoxifen, that a long term study on women be conducted.

• Feldmann 1989 reports a reduction in bone mass in a study on rats fed withkeoxi fene, but indicates that there may be a dosage problem.

• 1991,Turner published a paper comparing Jordan and Feldmann and prefersJordan.

27 Merck & Co v Apotex Inc, 2010 FC 1265 at para 498, 91 CPR (4th) 1, aff’d 2011 FCA 363, 102 CPR (4th) 321 (lovastatin). See also Teva v Novartis, supra note 12 at para 271.

28 2008 FC 142 at para 157, 63 CPR (4th) 406 (raloxifene) [Eli Lilly Canada v Apotex FC].


• March1992,Loveandothers includingJordancarry Jordan’swork furtherbyadministering tamoxifen to postmenopausal women with breast cancer and report the results to be “reassuring.”

• July28,1992,the“priority”applicationrespectingthe’356patentisfiledintheUnited States, contents are unknown but presumably similar or identical to the disclosure of the ’356 patent.

• March1993,ataconferenceinHongKongEliLillypublishesanabstractofastudy conducted on 251 post-menopausal women who took a placebo or various dosages of raloxifene. It states that raloxifene “shows promise.”

• July27,1993,theCanadianapplicationforwhatbecomesthe’356patentisfiled.It discloses four examples of rat studies and a fifth example of an anticipated or not concluded study on 160 post-menopausal women where certain results are “expected” and a long term study recommended.

• January1994,thusnotpartofthepriorart,Blacketal.publishapaperdiscuss-ing a study on rats fed with raloxifene, not humans, which concludes that raloxi-fene “might offer” a useful therapy for post-menopausal women to maintain bone mass.29

Adopting a holistic view of patent law, Hughes J considered obviousness, sound prediction, and sufficiency of disclosure together.30 He held:

[154] Eli Lilly says that, as of the priority date, only Black had sufficiently robust rat studies such as would lead him, but only him at the time, to predict with confi-dence that raloxifene would be effective in treating osteoporosis and bone loss with-out, to take their construction of the matter, unwanted estrogen related effects.

[155] I find, taking all of the relevant evidence into consideration, that as of 1992, the words used by Turner in 1997 would have been appropriate. To a person skilled in the art, Jordan’s model and those used in other papers such as Turner’s own, would have been very, very good predictors of the effect of pharmacological agents on the skeleton at least regarding estrogen deficiency induced bone loss.

29 Ibid at para 124.

30 Compare Genpharm v Procter & Gamble Pharmaceuticals, 2004 FCA 393 at para 47, 37 CPR (4th) 289 (polyphosphonates), where Rothstein JA adopted the submission of then counsel for P & G, Roger Hughes:

As counsel for P & G has pointed out, sound prediction and obviousness are considerations with different perspectives. Sound prediction is relied upon by an inventor to justify patent claims whose utility is not actually demonstrated but can be soundly predicted from infor-mation and expertise that is available. Obviousness is relied upon by a potential competitor of the patentee, who argues that what is claimed in a patent is something that a skilled tech-nician keeping up with the state of the art and common general knowledge would be able to come to directly and without difficulty in the absence of the solution taught by the patent. These are different concepts and they are not to be conflated. The doctrine of sound predic-tion has no application to the doctrine of obviousness.


[156] The study reported in the Hong Kong abstract in 1993, where postmeno-pausal women were in fact treated, I find to be sufficient to turn that prediction into a sound prediction.

[157] Thus the prediction that a person skilled in the art in 1992, the priority date, could reasonably make was turned to one that such a person would soundly or inevit-ably make as of the Canadian filing date in 1993.

[158] To reduce these conclusions to the patent lingo, the claimed invention was not obvious as of 1992 but was soundly predictable by 1993.31

Hughes J also found (at para 123) that the inventors’ 1994 article (after the Can-adian filing date) discussed only a study involving rats, not humans, and concluded by saying that raloxifene might offer a useful therapy for post-menopausal women. This implies that the inventors did not rely on the Hong Kong study to make a pre-diction either before or after the Canadian filing date. The Hong Kong study was done by others at Eli Lilly—namely, Draper et al. Hughes J never made a finding that the inventors made a prediction based on their own work and the work of Draper et al, perhaps because he assessed the soundness of the prediction at the different dates from the objective point of view of the skilled person.

It is true that whether an invention is novel, unobvious, and useful must be as-sessed objectively. But there is a difference between assessing whether an invention is useful and whether the inventors have determined that it was useful. There are at least three problems with using a skilled person to evaluate invention-making pre-dictions of utility.

First, the patent bargain requires inventors to make an invention to supply the ne-cessary consideration for the grant of a monopoly to them or those claiming under them. Utility is an essential aspect of an invention and, when utility is predicted, the inventors must make this prediction, and soundly, to qualify as having made the in-vention. As Snider J held, the assessment of the soundness of their prediction is bounded by the knowledge, activities, and endeavours of the inventors themselves. The wisdom of this is illustrated in the example presented by Eli Lilly Canada v Apotex. The study by Draper et al, reported in the Hong Kong abstract, could not have a retroactive effect to make sound the inventors’ prediction if it was unsound when it was made. Otherwise, Draper’s study would also make sound the predictions of prior art researchers such as Jordan, Feldmann, Turner, and Love. The inventors might have made a new prediction based on their own work and the published work of Draper et al. They might have collaborated with Draper et al as co-inventors. They might have retained Draper et al to do non-inventive confirmatory studies on their behalf such as NIH did in AZT.32 But the inventors, Black et al, at some point in

31 Eli Lilly Canada v Apotex FC, supra note 28 at paras 154-158.

32 See the discussion of inventorship in AZT, supra note 5 at paras 94-106; compare with the situation regarding chain of title in 671905 Alberta Inc v Q’max Solutions Inc, 2003 FCA 241 at paras 37-40, [2003] 4 FCR 713, 27 CPR (4th) 385.


time had to make a prediction of utility that was sound when they made it. Whether a skilled person would soundly or inevitably make this prediction at some point in time does not address the question: “Did the inventors make this invention?”

Second, it is incongruous that utility must be something that a skilled person would inevitably predict soundly when other aspects of an invention such as novelty and ingenuity—that is, non-obviousness—are defined as beyond the ken of a skilled person. Hugesson J famously described the skilled person or skilled techni-cian as

having no scintilla of inventiveness or imagination; a paragon of deduction and dex-terity, wholly devoid of intuition; a triumph of the left hemisphere over the right.33

Novel subject matter is not known to a skilled person. Non-obvious subject matter is beyond the capacity of a skilled person. Similarly, it would be impossible for a skilled person having no scintilla of inventiveness or imagination to predict soundly an unobvious utility. Sound prediction should not be defined so narrowly as to ex-clude inventive, but sound, predictions of utility.

Third, in advanced research, the inventors’ expert knowledge and reasoning ap-plied to their experimental data may demonstrate that their prediction is logical and probative to their peers, who share a deep understanding of the science, but make less sense to the person of average skill. The law should not disregard inventions based on predictions of utility, which are sound to leading scientists, because a per-son of average skill would not understand why this is so. Teaching the person of average skill is a disclosure issue, not an invention-making issue.

A subjective approach resolves these problems. In the example above, the issue of whether the inventors soundly predict that their proposed treatment of post-menopausal women for bone loss would be “useful” should be determined subjec-tively from the knowledge, activities, and endeavours of the inventors themselves at the time that they make the prediction, having regard to their level of scientific understanding. If their prediction is contained in the Canadian patent application, then what the inventors consider up to the filing date is relevant. But information not considered by the inventors, even publicly available information, is not relevant.

In Eli Lilly Canada v Apotex, Hughes J went on to consider the disclosure, where the objective skilled person standard is clearly required, and held:

[163] The third criterion however is that of disclosure. It is clear that the ’356 pat-ent does not disclose the study described in the Hong Kong abstract. The patent does not disclose any more than Jordan did. The person skilled in the art was given, by way of disclosure, no more than such person already had. No “hard coinage” had been paid for the claimed monopoly. Thus, for lack of disclosure, there was no sound prediction.34

33 Beloit Canada Ltd v Valmet Oy (1986), 8 CPR (3d) 289 at 294, 64 NR 287 (FCA).

34 Eli Lilly Canada v Apotex FC, supra note 28 at para 163.


The Federal Court of Appeal agreed that the disclosure was insufficient because it disclosed no more than was previously known. It is noteworthy, however, that it was not argued on the appeal whether the Hong Kong study made sound the earlier prediction of the inventors, so this point was not fully explored. The court held:

[16] Absent a legal error, a decision as to whether or not a prediction is sound gives rise to a question of fact which cannot be overturned in the absence of a palpable and overriding error.

[17] In this respect, the appellant properly accepted that the Hong Kong study was necessary to make the prediction underlying the ’356 Patent sound. After taking all of the relevant evidence into consideration, it was open to the Federal Court Judge to find that as of the priority date the prior art Jordan article and the disclosure of the ’356 Patent were at the same point given that both studies demonstrated positive effects in respect of bone loss in rats and both concluded that human studies were warranted. In particular, the ’356 Patent did not disclose any more than the Jordan article did, and as such, the person skilled in the art was given, by way of disclosure, no more than such a person already had available in the prior art.35

This Federal Court of Appeal decision is a leading authority on the need for en-hanced disclosure and will be discussed again below; however, it seems clear that the court’s consideration of enhanced disclosure for sound prediction was not re-quired by its decision. The holding that the patent disclosed no more than what was known and published by persons other than the inventors was dispositive.

5.0 PROBABLY USEFUL: SOUND PREDICTION AND DEMONSTRATION

Whether an invention is useful is a question of fact and subject to proof. There is only one standard of proof in civil cases, the balance of probabilities.36 Therefore, the “useful” requirement in section 2 can be met by showing that an invention is useful on a balance of probabilities. There is no apparent need to clothe the civil standard of proof in adornments such as “strongly suggestive” or “self-evident”; a balance of probabilities is clear enough. It would do no violence to the law to say that the practical requirement of section 2 is that an invention must be “probably useful.”

Although the sound prediction of utility seems to have taken on a life of its own, it is not a new type of utility or a quasi-utility. The Act provides no protection for work that is almost, but not quite, an invention. The factual basis and line of reason-ing supporting a prediction of utility are simply evidence. If on balance the evi-dence shows probable utility, then the utility requirement of section 2 is satisfied, and once this threshold is reached, further or better proof is immaterial.

35 Eli Lilly Canada Inc v Apotex Inc, 2009 FCA 97 at paras 16-17, 78 CPR (4th) 388 (raloxifene) [Eli Lilly Canada v Apotex FCA].

36 See e.g. FH v McDougall, 2008 SCC 53, [2008] 3 SCR 41.


Similarly, a demonstration is simply evidence of utility. A demonstration may provide conclusive proof—for example, the Wright brothers fly their plane. Or it may provide inconclusive but probable proof—for example, in a statistically sig-nificant study a drug appears to treat a condition in humans. It is immaterial to es-tablishing the fact of utility whether a demonstration provides conclusive proof or merely probable proof.

In AZT, Binnie J seems to have treated a demonstration as a test that is conclusive proof of utility.37 However, later authorities have included, within the compass of “demonstration,” tests that are not conclusive but only probative of utility. For ex-ample, in Astrazeneca Canada Inc v Mylan Pharmaceuticals ULC,38 Rennie J held:

[168] For the purposes of demonstrating utility, it is sufficient that the test results are strongly suggestive of utility and that no other logical explanation for the test re-sults is likely.39

Rennie J also observed40 that in Pfizer v Novopharm,41 Kelen J held that a dem-onstration did not need to be conclusive. Similarly, Snider J so held in Teva Canada Limited v Novartis AG42 and Novartis Pharmaceuticals Canada Inc v Apotex Inc.43 Snider J observed that a number of experiments may require a commonsense ap-proach; failure of an experiment to show evidence of utility may indicate a failed experimental procedure rather than a failed demonstration of utility. In Eurocopter FC,44 the court noted that a demonstration was sufficient disclosure of utility on a balance of probabilities although it did not include all possible inclinations of the landing gear:

[354] On a balance of probability, the Court is satisfied that the utility of an em-bodiment included in claim 15 of the ’787 Patent was demonstrated at the Canadian filing date. The Court accepts the opinion of Eurocopter’s experts that a POSITA would not have tested all possible inclinations of the integrated front cross piece, which, according to claim 15, is offset forwards in relation to the front delimitation of the plane of contact of the longitudinal support surfaces of the skids on the ground.45

37 E.g. as noted earlier, AZT, supra note 5 at para 56:

[56] Where the new use is the gravamen of the invention, the utility required for pat-entability (s. 2) must, as of the priority date, either be demonstrated or be a sound prediction based on the information and expertise then available (emphasis in original).

38 2011 FC 1023, 96 CPR (4th) 159 (anastrolzole).



41 2009 FC 638 at para 87, 76 CPR (4th) 83 (sildenafil).

42 Teva v Novartis, supra note 12 at paras 213-215.

43 Ibid.

44 Supra note 10.

45 Ibid at para 354. The Federal Court of Appeal in Eurocopter FCA, ibid at para 148, tiptoed around the issue of what could distinguish a demonstration for a sound prediction as follows:


It seems clear and sensible that a balance of probabilities is the appropriate legal standard of proof for both demonstrations and sound predictions.

There is a possible caveat, however, which concerns the role of scientific stan-dards. Experts may apply a scientific standard, such as a confidence level to statis-tical results, to determine the scientific validity and significance of what has been tested. A 51 percent positive test result may not be scientifically meaningful for var-ious reasons—for example, it may fall into the margin of error for that type of ex-periment. Also, as Snider J observed above, experiments may fail for a variety of reasons not related to the hypotheses being tested. The legal standard of proof should be applied to weigh the scientifically significant evidence of utility (or the absence of such evidence).

In the context of the foregoing decisions, it seems that whether a test or experi-ment is called a demonstration or a factual basis for a sound prediction is a matter of semantics, not principle. It is not a question of quid pro quo. What a court calls a test or experiment does not depend on whether utility is the gravamen of the inven-tion. The experiments that were held to be demonstrations by Rennie and Snider JJ would also serve as bases for a sound prediction of utility.

This brings into question the enhanced-disclosure rule. The Federal Court does not require disclosure of any details of a demonstration,46 but, under the enhanced-disclosure rule, demands disclosure of the factual basis and line of reasoning for a sound prediction. If an undisclosed experiment is called a demonstration, the patent is valid, but if it is called a factual basis for a sound prediction, the patent is invalid. A rose by any other name would smell as sweet.

6.0 PROPER DISCLOSURE: THE ONUS OF PROVING UTILITY TO THE COMMISSIONER

Perhaps the first of the statutory requirements for disclosure of a sound prediction that should be considered is that raised by Binnie J in AZT, where he used section 40 to support his decision that an inventor must be able to establish utility before filing.

Part of what Binnie J said was quoted earlier in the context of the final date for establishing utility. A more complete excerpt follows:

[148] It seems to me that calculations and mathematical modeling are, by their very es-sence, a prediction of a given utility. I however recognize that there may be situations where a mathematical prediction of utility may be equivalent to a demonstration of utility, depending on the nature of the technology being mathematically modeled and the degree of reliability which experts would afford to such models for such purposes. I need not how-ever address this issue in this case..

46 There is no requirement to prove demonstrated utility in the disclosure so long as the disclosure re-fers to a study demonstrating that the patent does what it promises to do: Novopharm Limited v Pfizer Canada Inc, 2010 FCA 242 at para 90, 88 CPR (4th) 405 (sildenafil), and Apotex Inc v Pfizer Canada Inc, 2011 FCA 236 at para 30, 95 CPR (4th) 193 (latanoprost).


[46] … Utility is an essential part of the definition of an “invention” (Patent Act, s. 2). A policy of patent first and litigate later unfairly puts the onus of proof on the at-tackers to prove invalidity, without the patent owner’s ever being put in a position to establish validity. Unless the inventor is in a position to establish utility as of the time the patent is applied for, on the basis of either demonstration or sound prediction, the Commissioner “by law” is required to refuse the patent (Patent Act, s. 40).47

A narrow construction of Binnie J’s remarks would not require an applicant to establish utility to the commissioner, but simply be in a position to do so. However, the full paragraph seems to suggest that the applicant has an onus under section 40 to establish to the satisfaction of the commissioner that the invention has utility. This view is consistent with Binnie J’s apparent opinion that a patent specification should include the factual basis and line of reasoning underlying a sound prediction of utility—that is, enhanced disclosure. But to this extent his opinion is obiter dicta, because the Supreme Court in AZT avoided deciding this point. Nevertheless, this is important obiter and is significant to any argument about enhanced disclosure. It will therefore be considered here.

Binnie J’s obiter comment in AZT must be compared with the ratio decidendi of the Supreme Court in Monsanto v The Commissioner of Patents48 (Monsanto), where the issue of the onus under section 40 (then section 42) before the commis-sioner was squarely before the court in a case involving sound prediction.

Here, rather than put the onus on the applicant to satisfy the commissioner, the court put the onus on the commissioner to justify any refusal. The fact that the com-missioner was not satisfied with the applicant’s factual basis for its prediction of util-ity was insufficient. The court quoted Duff CJ, stating that a refusal is not a matter of discretion; the commissioner ought not to refuse an application unless it is clear-ly without foundation. In saying so, the court took quite a different view from that of Binnie J in AZT regarding the significance of the words “by law” in section 40.

Pigeon J, speaking for the court, said:

Although the report of the Board is quite lengthy, in the end with respect to claim 9 all it says after stating the principle with which I agree, is that a claim has to be restricted to the area of sound prediction and “we are not satisfied that three specific examples are adequate.” As to why three is not enough nothing is said. In my view this is to give no reason at all in a matter which is not of speculation but of exact science. We are no longer in the days when the architecture of chemical compounds was a mystery. By means of modern techniques, chemists are now able to map out in detail the exact dis-position of every atom in very complex molecules. It, therefore, becomes possible to ascertain, as was done in Olin Mathieson, the exact position of a given radical and also to relate this position to a specific activity. It thus becomes possible to predict the

47 AZT, supra note 5 at para 46 (underlining added).

48 [1979] 2 SCR 1108, 42 CPR (2d) 161 [Monsanto].


utility of a substance including such radical. As this is a matter of general knowledge among scientists, it will be readily apparent to a competent person that if a patent cov-ers only a few of the substances which yield the desired result, all he has to do is to prepare another which will have the same properties. The report of the Board indicates that it is aware of this. However, it gives no indication of the reasons for which it was not satisfied of the soundness of the prediction of utility for the whole area covered by claim 9. Evidence had been submitted in the form of affidavits based on scientific principles, it does not take issue with those principles, it just says: “We are not satis-fied that this is adequate.” In my view this is insufficient because, if accepted, it makes the right of appeal illusory. In this respect it is important to note that s. 42 of the Pat-ent Act reads:

42. Whenever the Commissioner is satisfied that the applicant is not by law entitled to be granted a patent he shall refuse the application and, by registered letter addressed to the applicant or his registered agent, notify the applicant of such refusal and of the ground or reason therefor.

I have underlined by law to stress that this is not a matter of discretion: the Com-missioner has to justify any refusal. As Duff C.J. said in Vanity Fair Silk Mills v. Com-missioner of Patents [[1939] SCR 245] (at p. 246):

No doubt the Commissioner of Patents ought not to refuse an application for a patent unless it is clearly without substantial foundation.49

It would appear that Monsanto is the binding authority regarding section 40.

However, this aspect exceeds the scope of this article. For the present purpose of considering the disclosure requirements for sound prediction, it is sufficient to say that Monsanto offers no support for the proposition that a patent specification must contain the factual basis and line of reasoning in enough detail to satisfy the com-missioner of patents, or anyone else, that a prediction of utility is sound.

7.0 PROPER DISCLOSURE: TWO SCHOOLS OF THOUGHT

As stated earlier, the Federal Court of Appeal has developed two schools of thought regarding the requirements of a “proper disclosure” for sound prediction, which are referred to herein as the “enhanced-disclosure” school and the “no-enhanced-disclosure” school.

7.1 Federal Court of Appeal: The Enhanced-Disclosure School

The leading case requiring an enhanced disclosure in the Federal Court of Appeal is Eli Lilly Canada Inc v Apotex Inc,50 on appeal from Hughes J. This decision was

49 Ibid at 1118-21, Pigeon J (emphasis in original).

50 Supra note 35.


discussed earlier under the subjective and objective analyses of sound prediction. Noel J, for the court, stated:

[14] The decision of the Supreme Court in AZT is particularly significant to the disposition of this appeal. According to AZT, the requirements of sound prediction are three-fold: there must be a factual basis for the prediction; the inventor must have at the date of the patent application an articulable and sound line of reasoning from which the derived result can be inferred from the factual basis; and third, there must be proper disclosure (AZT … [Apotex Inc v Wellcome Foundation Ltd, 2002 SCC 77, [2002] 4 SCR 153], at paragraph 70). As was said in that case (para. 70): “the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent mono poly.” In sound prediction cases there is a heightened obligation to disclose the underlying facts and the line of reasoning for inventions that comprise the prediction.51

This decision has been followed by the Federal Court of Appeal in Eli Lilly v Teva52 and Apotex Inc v Pfizer Canada Inc.53 The enhanced-disclosure doctrine was also employed by Mainville JA in Eurocopter FCA.54

7.2 Federal Court of Appeal: The No-Enhanced- Disclosure School

The leading case of the no-enhanced-disclosure school in the Federal Court of Ap-peal is Pfizer et al v Ranbaxy et al (Ranbaxy) per Nadon JA, who said:

[56] The Applications Judge was wrong in interpreting the disclosure requirement of subsection 27(3) of the Act as requiring that a patentee back up his invention by data. By so doing, he confused the requirements that an invention be new, useful and non-obvious with the requirement under subsection 27(3) that the specification dis-close the “use” to which the inventor conceived the invention could be put: see Con-solboard, at page 527. Whether or not a patentee has obtained enough data to substantiate its invention is, in my view, an irrelevant consideration with respect to the application of subsection 27(3). An analysis thereunder is concerned with the suffi-ciency of the disclosure, not the sufficiency of the data underlying the invention. Al-lowing Ranbaxy to attack the utility, novelty and/or obviousness of the ’546 patent through the disclosure requirement unduly broadens the scope of an inventor’s obliga-tion under subsection 27(3) and disregards the purpose of this provision.

[57] While it is true that subsection 27(3) requires that an inventor “correctly and fully describe” his invention, this provision is concerned with ensuring that the paten-tee provide the information needed by the person skilled in the art to use the invention as successfully as the patentee.55

51 Ibid at para 14.

52 2011 FCA 220 at para 47.

53 Supra note 46 at para 52, Trudel JA.

54 Supra note 10 at paras 149-154.

55 2008 FCA 108 at paras 56-57, 67 CPR (4th) 23 (atorvastatin).


The Federal Court of Appeal followed Ranbaxy in Novopharm Limited v Pfizer Canada Inc.56 This decision was reversed on appeal to the Supreme Court,57 but not on this point; as noted earlier, in obiter the Supreme Court indicated agreement that no enhanced disclosure was required. The Federal Court of Appeal also rejected an enhanced-disclosure requirement in Sanofi-Aventis v Apotex58 and Eli Lilly Canada Inc v Novopharm Ltd.59

7.3 The Federal Court

These two schools in the Federal Court of Appeal have created some confusion in the Federal Court. For example, in Eli Lilly v Novopharm,60 O’Reilly J considered a selection patent containing a prediction of utility. He held:

[138] In my view, the two disclosure requirements are, in a case like this, coexten-sive. That is, if the disclosure requirements for sound prediction had been met, so would the disclosure requirements for a selection patent. If the patent had set out the factual basis and line of reasoning on which the assertions of substantial and special advantages were based, then the disclosure requirements for a valid selection patent would have been satisfied. I have already concluded, therefore, that the ’113 patent’s disclosure was insufficient.61

On appeal, the late Layden-Stevenson J, writing for the Federal Court of Appeal, set aside the judgment and held:

[121] The trial judge used what he considered to be the AZT requirement to deter-mine the sufficiency of the disclosure. He concluded that the disclosure was insuffi-cient because it did not meet the AZT hurdle. This approach is not consistent with the statutory requirements for sufficiency as set out in the Act and it is not consistent with the interpretation of those requirements set out in Ranbaxy. To reiterate, the patent must contain a disclosure of the compound and its advantage or advantages and a teaching of how it works.62

The case was then sent back to O’Reilly J for reconsideration, who said:

[272] I believe Lilly’s position is supported by Justice Layden-Stevenson’s discus-sion of sufficiency, as well as Pfizer Canada Inc. v Canada (Minister of Health), 2008 FCA 108. In my earlier judgment, I had interpreted the obligation to describe the in-vention and how it works as including, in the case of an invention based on an alleged

56 Supra note 46.

57 Teva v Pfizer, supra note 6.

58 Supra note 14.

59 2010 FCA 197, 85 CPR (4th) 413 (olanzapine) [Eli Lilly v Novopharm].

60 2009 FC 1018, 78 CPR (4th) 1 (olanzapine).


62 Eli Lilly v Novopharm, supra note 59 at para 121.


sound prediction of utility, the duty to set out the factual basis and line of reasoning supporting that prediction. Clearly, Justice Layden-Stevenson concluded otherwise and I am bound by her approach. The ’113 patent describes the compound of the in-vention, its advantages, how to make it, and the range within which it can be dosed. To require more—such as disclosure of the basis for the assertion that olanzapine has cer-tain advantages—would lead me to repeat the error in my original judgment identified by Justice Layden-Stevenson. I must conclude, therefore, that Novopharm’s attack on the sufficiency of the ’113 patent fails.63

Nevertheless, the Federal Court has generally applied the enhanced-disclosure requirement64—that is, until recently. In July 2014, Rennie J of the Federal Court rejected the notion that the enhanced-disclosure requirement is applicable to all cases of sound prediction.65 Rennie J referred to the AZT case, where Binnie J rea-soned that a sound prediction was the quid pro quo “in this sort of case.” Rennie J noted that the Federal Court of Appeal has interpreted AZT to mean that enhanced disclosure applies in all cases of sound prediction, citing Eli Lilly Canada Inc v Apotex Inc66 and Novopharm Ltd v Eli Lilly and Co.67 But Rennie J made the point that, in AZT, Binnie J was referring to second-use-type cases only, where a new utility is all that is being offered as the invention. For support, he cited Gauthier J in Sanofi-Aventis v Apotex:

[134] In contradistinction with the situation in AZT, where the invention claimed was the new use/utility and thus the quid pro quo for the grant of the monopoly was a full disclosure in respect of such utility, the public here received all the information necessary to make and use clopidogrel.68

Rennie J also took guidance from the Supreme Court’s obiter remarks in Teva v Pfizer, which are discussed below, and distinguished the Federal Court of Appeal decision in Eurocopter FCA.69

It remains to be seen whether this decision will spark a new trend in the Federal Court against requiring an enhanced disclosure in cases other than “new-use” cases.

63 Eli Lilly Canada Inc v Novopharm Ltd, 2011 FC 1288 at para 272, 100 CPR (4th) 269 (olanzapine).

64 Some examples include Novopharm Ltd v Eli Lilly and Co, 2010 FC 915 at paras 88-89, 87 CPR (4th) 301, aff’d 2011 FCA 220, 94 CPR (4th) 95 (atomoxetine); AstraZeneca Canada Inc v Mylan Pharmaceuticals ULC, 2011 FC 1023 at paras 186-191, 96 CPR (4th) 159, aff’d 2012 FCA 109, 101 CPR (4th) 275 (anastrozole); Apotex Inc v Sanofi-Aventis, supra note 18 at paras 566-584.

65 AstraZeneca Canada Inc v Apotex Inc, 2014 FC 638 at paras 149-160 (esomeprazole).

66 Supra note 35 at para 14.

67 2011 FCA 220 at paras 47-51.




7.4 The Supreme Court of Canada

As noted above, in Teva v Pfizer,70 LeBel J, writing for the Supreme Court, dis-counted the enhanced-disclosure requirement as follows:

[39] That the invention must be useful as of the date of the claim or as of the time of filing is consistent with this Court’s comments in AZT, at para. 56:

Where the new use is the gravamen of the invention, the utility required for pat-entability (s. 2) must, as of the priority date, either be demonstrated or be a sound prediction based on the information and expertise then available. If a pat-ent sought to be supported on the basis of sound prediction is subsequently challenged, the challenge will succeed if … the prediction at the date of appli-cation was not sound, or, irrespective of the soundness of the prediction, “[t]here is evidence of lack of utility in respect of some of the area covered.” [Italics and underlining in original.]

[40] Nothing in this passage suggests that utility is a disclosure requirement; all it says is that “the utility required for patentability (s. 2) must, as of the priority date, either be demonstrated or be a sound prediction.” Utility can be demonstrated by, for example, conducting tests, but this does not mean that there is a separate requirement for the disclosure of utility. In fact, there is no requirement whatsoever in s. 27(3) to disclose the utility of the invention: see, e.g., Consolboard, at p. 521, per Dickson J.: “I am further of the opinion that s. 36(1) [now s. 27(3)] does not impose upon a paten-tee the obligation of establishing the utility of the invention.”71

These comments were obiter,72 since LeBel J noted:

[43] Since sound prediction is not an issue, the question whether there is an “en-hanced” or “heightened” disclosure requirement with respect to sound predictions does not arise in this case and need not be addressed.73

8.0 PROPER DISCLOSURE: THE ACT

In the Supreme Court decision in Commissioner of Patents v Fabwerks Hoechst Ak-tiengeselschaft Vormals Meister Lucius & Bruning,74 Judson J set out a basic tenet of patent law that has been a touchstone in many cases and bears repetition here:

70 Supra note 6.

71 Ibid at paras 39-40 (bold emphasis added).

72 Hughes J has so held in Pfizer Canada and Warner Lambert Company Inc v Pharmascience Inc and Minister of Health, 2013 FC 120 at para 156, 111 CPR (4th) 88 (pregabalin); see also Euro-copter FCA, supra note 10 at para 151 to the same effect. But see Rennie J’s reliance on them supra note 65 and accompanying text.

73 Teva v Pfizer, supra note 6 at para 43.

74 [1964] SCR 49, 41 CPR 9.


There is no inherent common law right to a patent. An inventor gets his patent accord-ing to the terms of the Patent Act, no more and no less.75

8.1 Section 2

Section 2 of the Act defines an “invention” as having novel and useful subject mat-ter. Being only a definition, section 2 does not impose any obligations on an inven-tor or an applicant for a patent.

Section 2 requires an invention to be novel. The subject matter of an invention may or may not be novel and unobvious, regardless of what an inventor may think. An inventor may erroneously believe that a particular aspect of an invention is novel when applying for a patent, but later, during examination in the Patent Office or even at trial, it may be shown that this aspect is known. Nevertheless, the patent may be held to be valid because some other aspect, to which the inventor gave no credit, is novel and unobvious. Fletcher-Moulton LJ eloquently makes this point in British United Shoe Machinery Company Ld v A Fussell & Sons Ld 76 (Fussell), ex-plaining that if the law required an inventor to know and disclose how an invention is novel, it would impose an impossible burden on an inventor to know all the pos-sibly relevant prior art. Dickson J refers to this in Consolboard:

The impossible and unwarranted nature of such a burden was explicitly identified by Fletcher-Moulton L.J. in British United Shoe Machinery Company Ld. v. A. Fussell & Sons Ld. at p. 652.77

Section 2 also requires an invention to be useful. This is consistent with the fore-going interpretation of section 2 that an invention may be useful whatever the in-ventor might think. Utility is different from novelty, however; there is no undue burden. An inventor need not be aware of all prior art to appreciate a utility of his or her invention. But utility is similar to novelty in that an inventor’s limited under-standing of the utility of the invention is not limiting of the inventor’s rights. Inven-tors are entitled to monopolize uses of their inventions that they never contemplated—for example, a monopoly over a new compound for all its uses, even those that the inventor does not contemplate.78

In summary, section 2 is not concerned with the inventor’s understanding of nov-elty or the extent of utility. It is an abstract definition that imposes no disclosure requirements.

75 Ibid at 57; referred to in Harvard College v Canada (Commissioner of Patents), 2002 SCC 76, [2002] 4 SCR 45; Monsanto Canada Inc v Schmeiser, 2004 SCC 34, [2004] 1 SCR 902; Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61, [2008] 3 SCR 265 (clopidrogel).

76 (1908), 25 RPC 631 at 651-52 (CA).

77 Supra note 1 at 532.

78 Apotex Inc v Wellcome Foundation Ltd, [2001] 1 FC 495 at para 27, 10 CPR (4th) 65, Rothstein JA (FCA) [AZT FCA].


8.2 Section 27 and Consolboard

Sections 27(2) and (3) require a specification that correctly and fully describes the invention and its operation or use as contemplated by the inventor.

Consolboard 79 is the leading case on the meaning and the extent of the disclo-sure requirement of a specification. In that case, the Supreme Court considered the meaning of section 36(1), which was then the counterpart of section 27(3); how-ever, sections 36(1) and 27(3) are dissimilar on the exact point in issue in Consol-board. At the time of this decision, section 36(1) contained a concluding clause stating the following:

[H]e shall particularly indicate and distinctly claim the part, improvement or combina-tion which he claims as his invention.

This clause has since been repealed, but it is important to keep in mind when reading the reasons for judgment, particularly the following celebrated quote of Dickson J:

Section 36(1) did not require a distinct indication of the real utility of the invention in question, and its concluding words did not require the inventor to describe in his dis-closure or claims how the invention was new or useful. The inventor was required to describe what it was he claimed to have invented, but not to extol its effect or advan-tage if he described the invention so as to produce it. The requirement in s. 36(1) that the specification disclose the “use” to which the inventor conceived the application could be put related to disclosure and was independent of the requirement in s. 2 that an invention be new and “useful” as a condition precedent to an invention.80

The emphasized words in this quotation are important. Dickson J was comment-ing on an interpretation by Jackett CJ of the Federal Court of Appeal about the dis-closure requirements of section 36(1) or, more precisely, section 36(1) read in light of the words “particularly indicate and distinctly claim” in its concluding clause. Jackett CJ read these words as an important facet of the disclosure requirement of section 36(1), independent of and in addition to the requirement for the claims in section 36(2). Dickson J summed up Jackett’s CJ reasoning as follows:

The Chief Justice held that an invention must in the case of a product, (which he con-sidered to be involved here) by virtue of the definition of “invention” be “useful … composition of matter, or any … useful improvement in any … composition of matter.” Having affirmed that the trial judge had correctly described the “invention” the Chief Justice said:

In our view, having regard to the obvious object of section 36 of making “patent” to the public (as a consideration for the monopoly) all aspects of the invention (in the sense defined by section 2 of the Patent Act) and particularly

79 Supra note 1 at 505-6.

80 Ibid (emphasis added).


its utility, there is no compliance with that section unless the applicant in his specification distinctly claims the “part, improvement or combination which he claims” having “correctly and fully” described, inter alia, its utility.

He continued:

After studying the “specification” and in the light of a long argument and refer-ences to the voluminous evidence, it would seem that the utility of the invention consists of the fact that, if particles of wood created by crosscutting and tapered at the ends are used within the sizes mentioned, for the making of fibre boards, they will produce a relatively inexpensive board strong enough for construction purposes because there has been a minimization of the damage to the fibres and the tapering at the ends of the particles reduces the amount of the relatively ex-pensive bonding resin required and, by virtue of the overlapping resulting from such tapering, results in a stronger board.

and concluded:

In our view, while the reduction in damage to the wood fibres, as a utility to be achieved by the “invention,” is “distinctly” claimed by the patent (see page 1 of the printed copy), the utility of the combination of the crosscutting whereby that is achieved and the tapering of the ends of the particles is only to be dis-covered by an intensive study of the patent, if at all. The main reference to it is in Column 8 (out of 16 columns) in a discussion of a particular application of the “invention.” In our view, this is not a distinct indication of the real utility of the invention in question by which the public would be made aware of the in-vention in the manner required by section 36; and the Patent Act does not, therefore, authorize a monopoly for the invention.81

In other words, Jackett CJ was of the view that, although the utility was disclosed on page 1 of the specification,82 a distinct explanation of how the specific combina-tion of the features of the wood chips would achieve this utility could not be found; it could only be learned from studying the whole specification and even then was difficult to discern. This, he held, was inadequate to particularly and distinctly indi-cate the utility aspect of the invention as the last clause of section 36(1) required.

81 Ibid at 516 (emphasis in original).

82 Collier J in the Federal Court and Jackett CJ in the Federal Court of Appeal refer to the columns of the patents in their decisions. Collier J in an endnote says that he is referring to the printed versions of the patents issued by the Patent Office. Apparently, the Queen’s Printer in those days printed issued patents in a column format. Upon retrieving from CIPO and reviewing the printed issued patent that Jackett CJ discussed in his decision, I believe that what Jackett CJ was referring to at “page 1 of the printed copy” was: “A further object of the invention in one form is to provide a moulded product from wood flakes, wafers and the like in which the intrinsic strength of the fibre is preserved and which are smooth and have tapered ends and good board making properties re-quiring very little added binder” (emphasis added). This is based on identification in the specification that “[i]n general the defibering methods of the prior art are such that a substantial proportion of the inherent strength of the wood fibre is destroyed by the act of defibering.”


Dickson J gave the last clause of section 36(1) little regard. He held:

It is not entirely clear what was intended to be achieved by the addition of the quoted words. They may have been added ex abundante cautela, seeking greater particularity of description, but they appear to be little more than pleonasm, when read with s. 36(2) and the definition of “invention.” It is not readily apparent that anything of substance was added in 1935 to that which had been required since 1869.83

He continued:

In my respectful opinion the Federal Court of Appeal erred also in holding that s. 36(1) requires distinct indication of the real utility of the invention in question.84

It was in the context of this disagreement over the requirement for a “distinct” indication of utility in the concluding words of section 36(1) that Dickson J said:

I do not read the concluding words of s. 36(1) as obligating the inventor in his disclo-sure or claims to describe in what respect the invention is new or in what way it is use-ful. He must say what it is he claims to have invented. He is not obliged to extol the effect or advantage of his discovery, if he describes his invention so as to produce it.85

This famous statement has taken on a meaning that goes beyond the context in which it was made. It is often referred to as an authority for the proposition that the Act does not require disclosure of the utility of the invention.86 It is submitted that this was not what Dickson J intended. Recall that Jackett CJ said that the utility was disclosed:

In our view, while the reduction in damage to the wood fibres, as a utility to be achieved by the “invention,” is “distinctly” claimed by the patent (see page 1 of the printed copy) … .

The issue was not a requirement to disclose the utility of the invention, but rather a requirement that the specification must particularly and distinctly explain how this utility would be achieved by the combination of wood chips. Given that section 36(1) mandated disclosure of the invention and its operation or use as contemplated by the inventor, it would require a razor-sharp interpretation to exclude disclosure of utility from this requirement. Disclosure of the use of an invention surely must include its utility. Imagine a disclosure that describes, for example, the composition of a new drug, how to make it, the dosage, and how to take it, but never discloses the utility of the drug—that is, what it is useful to treat. This would not teach the in-vention to the public.

83 Consolboard, supra note 1 at 519.

84 Ibid at 525.

85 Ibid at 526.

86 See e.g. Teva v Pfizer, supra note 6 at paras 38-40; Sanofi-Aventis v Apotex, supra note 14 at para 39; also referenced in Eurocopter FCA, supra note 10 at para 151.


As noted earlier, in AZT, Binnie J approvingly quoted Jackett CJ: “Knowing a new process without knowing its utility is not in my view knowledge of an ‘inven-tion.’ ” Binnie J also moderated the idea that an inventor is not required to describe “in what way an invention is useful” by holding that disclosure of utility is not re-quired when utility would be obvious to a skilled person. He explained and distin-guished prior cases and patents:

In this case, Dr. Horwitz taught everyone how to make AZT. The question was what could usefully be done with it. In Ernest Scragg & Sons Ltd. v. Leesona Corp., [1964] Ex. C.R. 649, Thorson P. held that if the invention related to an apparatus or process, it was sufficient if the apparatus had actually been built or the process used. The inven-tion in that case was for “Thermoplastic Yarns and Methods of Processing Them” (p. 659). AZT had been compounded and used in 1964, but not by Glaxo/Wellcome, and not in relation to HIV/AIDS. The invention claimed here related entirely to the new and hitherto unexpected use. Glaxo/Wellcome also cites Koehring Canada Ltd. v. Owens-Illinois Inc. (1980), 52 C.P.R. (2d) 1 (F.C.A.) (leave to appeal refused, [1980] 2 S.C.R. ix), which dealt with an invention to harvest and process trees in the middle of a forest. The utility was obvious. The invention lay in the machine and its opera-tion. Glaxo/Wellcome also relied upon two Canadian appeals to the Privy Council for the proposition that “proof of utility is not required for there to be an invention” (fac-tum, para. 45): Permutit Co. v. Borrowman, [1926] 4 D.L.R. 285 (P.C.), and C.G.E. Co. v. Fada Radio Ltd., [1930] 1 D.L.R. 449 (P.C.). In neither case was utility in doubt. Permutit dealt with a process for softening water and Fada Radio dealt with a radio tuning device.87

It is submitted that, in the context of the issue before the court, what Dickson J meant in Consolboard about the disclosure requirement is captured more accurately in the following quotation from his reasons:

I am further of the opinion that s. 36(1) [now s 27(3)] does not impose upon a patentee the obligation of establishing the utility of the invention.88

In other words, there is no need to disclose the evidence or an explanation establish-ing—in the sense of proving or validating—the utility of an invention. This principle accords with the language of section 36(1), given Dickson J’s interpretation of its concluding clause, and goes directly to the heart of the issue in Consolboard.

This principle is also applicable to section 27(3), perhaps even more so, because the language of the concluding clause of section 36(1), at issue in Consolboard, has been repealed. It is consistent with the Supreme Court’s decision in Monsanto, dis-cussed above, and with the Federal Court of Appeal’s judgment in Novopharm Lim-ited v Pfizer Canada Inc.89 On appeal of this last case, the Supreme Court referred


88 Consolboard, supra note 1 at 521 (emphasis added).

89 Supra note 46.


to the foregoing quotation of Dickson J in its obiter remarks that section 27(3) does not impose on a patentee the obligation of establishing the utility of the invention.90

Let’s turn back to the words of section 27(3):

27(3) The specification of an invention must

(a) correctly and fully describe the invention and its operation or use as con-templated by the inventor.

Reading section 27(3) with AZT and Consolboard in mind, it seems that, at the level of understanding of a person of average skill in the art, the specification should describe the following: the invention, its utility, and how the inventor con-templates its operation or use to obtain this utility as successfully as the inventors could at the date of the application.91 All of this is subject to the rider that any part of this requirement may be unnecessary if the utility of the invention would be ob-vious to a skilled person reading the specification in light of the common general knowledge. It is not necessary that the specification particularly and distinctly indi-cate the utility in some concise statement, explain the theory of how the invention will obtain the contemplated utility, or prove that it will do so. It is of no conse-quence that the inventor does not appreciate all the advantages or uses of the inven-tion; this is not limiting of the inventor’s rights.

9.0 PROPER DISCLOSURE: SOUND PREDICTION— THE SKILLED PERSON STANDARD

The often-mentioned standard for the enhanced-disclosure rule for sound prediction is that the disclosure must divulge the factual basis and line of reasoning (unless it is common general knowledge) to a skilled person—for example, the following passages from the Federal Court of Appeal decision in Eurocopter FCA:

[152] In my opinion, the factual basis, the line of reasoning and the level of dis-closure required by the doctrine of sound prediction are to be assessed as a function of the knowledge that the skilled person would have to base that prediction on, and as a function of what that skilled person would understand as a logical line of reasoning leading to the utility of the invention.

• • •

[154] As noted in the Manual of Patent Office Practice issued by the Canadian Patent Office (at paras. 12.08.04b and 12.08.04c), since a sound line of reasoning is directed to a skilled person, those elements of the doctrine of sound prediction that would be self-evident to that person in view of the common general knowledge need not be explicitly disclosed in the specification. The soundness of a line of reasoning

90 Teva v Pfizer, supra note 6 at para 40.

91 The phrase “at the date of the application” assumes that the inventors have not made additional in-ventive improvements to the original invention before the Canadian filing date.


can also be effectively assessed by asking whether the skilled person would accept the logic presented in the specification and derive from the sound prediction as a whole an expectation that the invention will provide the promised utility.92

There can be no question that, if one accepts the premise that the factual basis and line of reasoning are to be disclosed, they must be disclosed at the level of under-standing of the notional person of average skill in the art. If the inventors are oper-ating at an expert level of knowledge and skill, then the disclosure must be “dumbed down” to explain these matters to the person of average skill. To the ex-tent that the above-quoted paragraphs are saying this, there can be no quarrel.

But these paragraphs go further. They suggest that the sufficiency of the disclo-sure depends on whether a skilled person would accept the logic presented and de-rive an expectation that the invention will provide the promised utility. This sounds a lot like requiring an inventor to establish utility in the disclosure to the satisfac-tion of the person of average skill. The proposition that the patentee must establish the utility of the invention in the specification has been clearly rejected by the Su-preme Court in Consolboard and appears to be inconsistent with Monsanto, dis-cussed above. There was insufficient support for such a requirement in section 36(1), and there is even less support in its present-day counterpart, section 27(3), given the repeal of the last clause of section 36(1).

It is submitted that there is no basis in the statute for requiring a patentee to es-tablish the soundness of a prediction of utility to the skilled person, or to anyone else, in the disclosure of a patent specification.

10.0 PROPER DISCLOSURE: WHEN MUST EVIDENCE OF UTILITY BE DISCLOSED?

One may begin here with the comment that it is usually good practice to disclose information about the utility of the invention, including demonstrations, factual basis, and line of reasoning—provided, however, that one does not fall into the trap of stating potential(s), goals, and foreseeable results as promises of utility.

The issue here, however, is when one must disclose experimental results, lines of reasoning, and demonstrations. The answer seems to be that one must disclose them when they are necessary to describe the invention and how it is to be operated or used as contemplated by the inventor.

An invention is a technical advance in the art. If one makes a sound prediction of utility, where there was previously only speculation, there would be no disclosure of a technical advance unless the new factual basis and the new line of reasoning for the prediction were disclosed. A good example is Eli Lilly, discussed above re-garding the Hong Kong study. The new experimental results had to be disclosed—

92 Eurocopter FCA, supra note 10 at paras 152 and 154.


not to establish the prediction of utility but to disclose the technical advance that constituted the invention. Whether a full, elaborate disclosure of the experiments and thinking or merely a summary needs to be disclosed depends on the nature of the invention.

Another reason to disclose the factual basis and reasoning would be to enable the skilled person to practise the invention as successfully as the inventors could at the filing date. The facts and reasoning of the inventors may provide a better under-standing of the invention or its potential that would benefit the skilled reader in util-izing the invention or in future research and development based on the invention. The public is entitled to benefit from this knowledge to the same extent as the in-ventors. But the further away one gets from the core requirement of disclosing the invention and how to operate and use it as contemplated by the inventor, the less an omission in the specification should affect validity. Perhaps this is when one should look to section 53, which provides that an omission in the specification will result in the patent being void only if it was made for the purpose of misleading the public.

The same may be said of demonstrations. A demonstration of what was previ-ously mere speculation may be the crux of the technical advance and therefore neces sarily disclosed to enable a skilled person to understand the invention. Simi-larly, information regarding the way in which the demonstration was conducted may be necessary for a skilled person to practise the invention as well as the inven-tors, and therefore should be disclosed.

Whether a demonstration or a factual basis and line of reasoning are essential to the disclosure of an invention and how it is operated or used will depend on the cir-cumstances of each invention. The point is to disclose what is new and useful and how to use it, not to establish or prove that it is new and useful.

11.0 CONCLUSION

The patent bargain is premised on the notion that in exchange for the monopoly the public obtains “solid teaching” from inventors of new and useful subject matter. The requirement that an invention be “useful” means that the inventors must have probative evidence of its utility at the time of filing their patent application. The re-quirement for “solid teaching” means that the patent specification must teach the public (represented by the skilled person) the invention and its operation or use as contemplated by the inventors. This must be done to ensure that the public can make the same successful use of the invention as the inventors could when the ap-plication was filed.

It is appropriate to assess a prediction of utility from the subjective perspective of the inventors and at the level of the inventors’ understanding of the art or science. What may be known to a skilled person is irrelevant unless it is known to the inven-tors. On the other hand, the teaching in the patent specification should be assessed objectively from the point of view of the person of average skill in the art.


A predicted utility is not a different kind of utility, or a quasi-utility, requiring special treatment either at the stage of invention-making or invention-disclosing. The factual basis and reasoning underlying such a prediction are simply evidence of utility. When utility is established on a balance of probabilities, the defined require-ment that an invention be useful is proven and the prediction is sound. Once this threshold is crossed, the quality or quantity of proof is immaterial.

For the purposes of disclosure, there is no principled basis to distinguish a pre-diction of utility from a demonstration of utility. A demonstration may be conclu-sive or simply probative of utility. It is inconsequential whether the evidence is conclusive; there are no degrees of utility or proof. The only standard of proof in civil cases is a balance of probabilities.

Consolboard does not stand for the principle that inventors do not need to dis-close utility—that is, how their invention is useful—but rather for the principle that inventors do not need to establish utility in the disclosure. For sound prediction, this means that disclosure of the inventor’s factual basis and line of reasoning is not re-quired to enable a skilled person to assess the soundness of a prediction of utility nor to enable a skilled person to make the sound prediction, an impossible burden if it is an inventive prediction.

Proper disclosure in all cases, including sound prediction cases, is no more and no less than that mandated by the Act. An applicant must disclose what is necessary to enable a skilled reader to understand the invention (the technical advance made by the inventors) and its operation or use sufficiently to make the same successful use of the invention as the inventor could at the time of the application. To serve these ends, it may be necessary in some cases to disclose a demonstration of utility or the factual basis and the line of reasoning for a prediction of utility. Whether this kind of disclosure is required can be determined ad hoc. There is no need to formu-late a special or “enhanced” disclosure rule for sound prediction.

Documents

PROBABLE UTILITY - Bereskin & Parr · 219 at para 146, 449 NR 111, Mainville JA [Eurocopter FCA], aff’g 2012 FC 113, 100 CPR (4th) 87, Martineau J [Eurocopter FC]. However, in Pfizer